Senior Clinical Trial Manager

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position summary

The Clinical Trial Manager (CTM) is accountable for end-to-end study operational oversight and delivery at country level, ensuring adherence to timelines, budget and quality standards. Acts as the primary point of contact at a country level for both internal and external stakeholders, ensuring clear communication, effective coordination, and successful project execution.

Position Responsibilities:

• Acts as the main point of contact for a country with global study team members and accountable for the coordination with local country cross functional teams.
• Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership.
• Plans, develops and executes timelines and activities for start-up in collaboration with the local study team, Global Trial Acceleration Centre (GTAC) and other relevant stakeholders.
• Implement country and site level patient recruitment strategy and risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met in collaboration with relevant stakeholders.
• Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s.
• Assessment and set up the of vendors during study start up period (locally) • Investigator Meeting participation and preparation.
• Ensures data entered in the Clinical Trial Management System (CTMS) is current and complete, and access to eDC and vendor systems is available for the country and clinical trial site personnel. This includes entering necessary data and uploading documents in eTMF.
• Validation of study related materials (i.e. protocol, ICF, patient material).
• Supports the review of country and site-specific documents (e.g. ICF, patient material), and where applicable may include the preparation of site level ICF and other documents.
• May support preparation of materials for Site Initiation Visits.
• Responsible for verifying and confirming with local team eTMF completeness (Country and Site level).
• Prepare investigator sites to conduct clinical trials through verifying acceptability of Clinical Trial Package (CTP) documentation.
• Acknowledges Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.
• Coordination of database locks and query follow up. Ensures timelines are met.
• Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities.
• Coordinates and completes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion.
• Coordinate study team meetings locally.
• Supports GTAC in the resolution of queries related to site invoices and supports in the coordination of patient compensation claims (if applicable).
• Collaborates with the local study team to support the management of site relationships (may include CRO related issues).
• May support Investigator Site Assessment Visits (ISAs) and Site Initiation Visits (SIVs).
• May perform site closure activities, including post-close out.
• May act as point of contact for Sites.
• As required per country requirements, perform or support the preparation of submissions to Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.
• Perform submission to Ethics Committees and governance offices, where applicable, including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission). Coordinate the MOH responses with regulatory and central teams, as applicable.
• May support the collection and distribution of documents to and from sites.
• Support the approval for closure of funds/POs.
• May update national registries where applicable.
• Serves as a coordinating resource on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and Legal.

Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned.

Qualifications & Experience

Degree/Certification/Licensure:

• Bachelor's or master's degree required. Field of study within life sciences or equivalent

Experience:

• At least 6 years of industry-related experience.
• Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiative
• Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other peer team members through a mentoring process using informal and/or formal presentations.
• Serve as a Subject Matter Expert (SME) in areas such as therapeutic area, systems or processes across the department with the opportunity to contribute at a regional or global level with this expertise.

Competencies:

• Deep understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs
• Knowledge and understanding of clinical research processes, regulations and methodology
• Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
• Demonstrated organizational and planning skills and independent decision-making ability
• Strong organizational and time management skills and ability to effectively manage multiple competing priorities
• Interpersonal, oral and written communication skills to influence, inform or guide others
• Good verbal and written communication skills (both in English and local language).

Software that must be used independently and without assistance:

• Microsoft Suite
• CTMS
• eDC
• eTMF

Travel Required (nature and frequency) - Occasional local travel requirement < 1 month/quarter

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

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If this posting is missing required information required by local law or incorrect, contact BMS at [email protected] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1606705 : Senior Clinical Trial Manager